Oncology Drug Development: Q&A with Ashley Willson
Q: So why is there so much buzz around oncology in the pharmaceutical industry?
A: Oncology drugs dominate today’s research focus with over >5500 molecules in development, representing over 35% of the total industry pipeline. In 2019, 10 new oncology drugs were approved by FDA, of which half had an orphan indication and all had been granted priority review.
Q: Can you explain some of the challenges drug developers face?
A: Given the number of molecules in development, there is so much pressure on development teams to identify successful drug candidates as quickly as possible, and accelerate patient access, particularly where no effective therapies are currently available. However, the oncology therapeutic area remains a challenging one to navigate and success rates are low. The likelihood that a molecule entering Phase I will reach market is around 10%, with the average duration of an oncology clinical trial taking 40% more time than other therapy areas due to the difficulty in patient recruitment.
Q: What trends are you seeing in the types of molecules in development?
A: Oncology drug development has seen a significant shift in focus over the past 20 years as molecule chemistries and drug technologies have improved. Historically most oncology drugs were cytotoxic compounds with poor safety profiles. However, in recent years a better understanding of cancer aetiology has improved drug target specificity of oncology compounds, leading to the advent of molecular target agents (MTA), with more favorable safety profiles. Targeted small molecules currently make up around 40% of the global oncology pipeline, whereas cytotoxins have fallen to just 7%. This movement has opened the opportunity to use more convenient dosage forms, with oral administration considered the gold standard for patient compliance. Understandably, compared to the intravenous dosage form, this move to oral administration brings a different set of biopharmaceutics challenges that need to be overcome.
Q: What experience does Quotient Sciences have in this space?
A: Over the past 5 years alone, Quotient has performed more than 300 projects on 91 different oncology drug candidates, for 66 biotech/pharma clients and spanning 34 different disease indications.
Q: What types of development and manufacturing services does Quotient provide to biotech/pharma companies developing oncology therapeutics?
A: As a fully integrated drug development, clinical testing and manufacturing organization, Quotient Sciences is well positioned to address the challenges associated with developing small molecule oncology therapeutics. We are dedicated to accelerating the development of new drugs for patients around the world providing individual services or fully integrated programs through our unique Translational Pharmaceutics platform. We have supported over 50 oncology programs during the last 5 years and our extensive formulation know-how, coupled with our agile and flexible approach to clinical and commercial manufacturing, makes us a valued end-to-end solution provider for the development, testing and manufacture of oncology drug products.
Q: Are there any specialized areas or unique services that Quotient provides?
Global demand and growth for targeted oncology therapeutics has led to an increase in the manufacturing of high potent active pharmaceutical ingredients (HPAPIs). This has driven the need for high potency handling capabilities, particularly high-containment manufacturing facilities. Handling of these ingredients in the drug supply chain requires specialized equipment and enclosure systems in order to avoid cross contamination, product protection and to ensure operator and environmental safety. Quotient’s global state-of-the-art facilities possess the necessary handling and containment capabilities needed when development and manufacturing high potency APIs. Our highly potent handling GMP manufacturing suites are outfitted with the necessary engineering controls to handle PBLEC levels 1 through to 5 dependent upon the type of compound, dosage form, manufacturing process and batch size required.
In addition to handling high potency API’s, Quotient Sciences has demonstrated that formulation flexibility in Phase 1 healthy volunteer trials can be used to develop “patient ready” formulations for oncology molecules in less than half the time of the industry standard. This is accomplished by the close integration of real-time manufacturing and clinical testing, as part of our unique platform called Translational Pharmaceutics, which uses a 14-day “make-test” cycle, enabling formulation decisions to be made in real-time based on emerging human data.
Q: Where in the drug development process does Quotient support oncology companies?
Quotient Sciences supports small molecule oncology drug programs from candidate selection through to commercial manufacture with expertise in niche therapies including orphan and pediatric indications. We are dedicated to accelerating the development of these medicines for patients around the world, providing individual services or fully integrated programs..
Our experience also includes late stage development and commercial product launch. We understand the manufacturing challenges that may arise such as low volume demands, small batch sizes, limited API availability and high variability in patient recruitment times. We specialize in developing customized programs, supporting batch sizes ranging from less than 1 kg and scaling up to over 500 kg for solid oral dosage forms and up to 350 L for liquid formats.
Quotient’s facilities have been inspected and approved by all major regulators , with expertise and to manufacture clinical and commercial product for the U.S., U.K., European and Japanese markets. From design of experiments (DoE), to registration batches and process validation, our team of formulation and manufacturing scientists have the experience needed in order to ensure a successful commercial launch.